Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) - Full Text View

Purpose

The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)

Condition	Intervention	Phase
Cervical Cancer Vulvar Cancer Vaginal Cancer Genital Warts Human Papillomavirus Infection	Biological: Comparator: V505 formulation 1 Drug: Comparator: V505 formulation 2 Biological: Comparator: V505 formulation 3 Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Biological: Comparator: Placebo (unspecified)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer Genital Warts Vaginal Cancer Vulvar Cancer Warts

Drug Information available for: Human Papillomaviruses

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen [ Time Frame: 4 weeks post dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen [ Time Frame: 4 weeks post dose 2 ] [ Designated as safety issue: No ]

Enrollment:	511
Study Start Date:	October 2007
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen.	Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.
Experimental: 2 Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen.	Biological: Comparator: V505 formulation 1 0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.
Experimental: 3 Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen	Drug: Comparator: V505 formulation 2 0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.
Experimental: 4 Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection	Drug: Comparator: V505 formulation 2 0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6. Biological: Comparator: Placebo (unspecified) 0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.
Experimental: 5 Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection	Biological: Comparator: V505 formulation 3 0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6. Biological: Comparator: Placebo (unspecified) 0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.

Eligibility

Ages Eligible for Study:	16 Years to 26 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Female between 16 to 26 years old
Has never had Pap testing or have only had normal Pap test results
Lifetime history of 0 to 4 sexual partners

Exclusion Criteria:

History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser
History of severe allergic reaction that required medical attention
Are pregnant
Received a marketed HPV vaccine
Currently enrolled in a clinical trial
Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520598

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00520598 History of Changes
Other Study ID Numbers:	2007_567, V505-001
Study First Received:	August 22, 2007
Last Updated:	June 22, 2011
Health Authority:	Australia: National Health and Medical Research Council

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Tumor Virus Infections
Vaginal Diseases
Condylomata Acuminata
Warts

Papillomavirus Infections
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Vulvar Diseases

ClinicalTrials.gov processed this record on May 16, 2013